Wound treatment containment apparatus

ABSTRACT

The invention relates to the treatment of wounds. In particular, the invention relates to systems, devices, and methods enabling treatment (e.g., debridement) of wounds with liquid, gas, or particles in a non-controlled setting while providing containment of contaminated liquid, gas or particles, thereby preventing exposure of individuals and surfaces in proximity to the patient to infectious materials. In certain embodiments, the systems and devices are conformable to the contours of a non-planar surface, such as the human body (e.g., to seal or partially seal the device or system to a portion of a human body).

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention is a continuation of U.S. patent application Ser.No. 13/223,453, filed Sep. 1, 2011, which claims priority to U.S.Provisional Patent Application Ser. No. 61/379,058, filed Sep. 1, 2010,and is a continuation-in-part of U.S. application Ser. No. 12/608,617,filed Oct. 29, 2009, now U.S. Pat. No. 8,636,709, which claims priorityto U.S. Provisional Application 61/109,360, filed Oct. 29, 2008, each ofwhich is incorporated by reference in their entireties.

FIELD OF INVENTION

The invention relates to the treatment of wounds. In particular, theinvention relates to systems, devices, and methods enabling treatment(e.g., debridement) of wounds with liquid, gas, or particles in anon-controlled setting while providing containment of contaminatedliquid, gas or particles, thereby preventing exposure of individuals andsurfaces in proximity to the patient to infectious materials. In certainembodiments, the systems and devices are conformable to the contours ofa non-planar surface, such as the human body (e.g., to seal or partiallyseal the device or system to a portion of a human body).

BACKGROUND

Chronic wounds have an enormous impact on the US population. Between1.3-3 million US individuals suffer from pressure ulcers (Kuehn (2007)JAMA 297:938-9; herein incorporated by reference). Of the 20 millionAmericans with diabetes, approximately 10-20% are at risk for developingdiabetic ulcers (Kuehn (2007) JAMA 297:938-9; herein incorporated byreference). Many millions more suffer from venous stasis ulcers,lymphedema, peripheral vascular disease, non-healing surgical wounds,and burn wounds. It is estimated that between 5-10 billion dollars arespent annually in the US on wound care for chronic wounds (Kuehn (2007)JAMA 297:938-9; herein incorporated by reference).

By nature, all wounds contain some degree of bacteria. Wounds withincreasing bacterial counts are said to be contaminated, then colonized,then critically colonized, and when the amount of bacteria exceeds 10⁵per gram of tissue, the wound is said to be “infected” although it mayor may not display the classic characteristics of infection such asfrank pus, inflammation, and erythema. Although grossly infected woundsmay represent a situation that requires more urgent intervention, it hasbeen demonstrated that any amount of bacteria in a wound is detrimentalto wound healing. Acute infections may occur in “fresh” acute wounds orin chronic wounds and may lead to tissue loss, limb loss, sepsis, oreven death.

The effect of bacteria on wound healing is multifactorial, the sum ofwhich is referred to as the bioburden. In general, the bacteria competewith the host for oxygen and nutrients, and create a pro-inflammatoryenvironment that resists host defenses and places a metabolic strain onthe wound. Normal growth factors and other pro-healing mechanisms may behindered or even degraded by the bacteria, the end result of which isthat wound healing is greatly prolonged. Over time, through adhesion toeach other and the secretion of a proteinaceous matrix, the bacteria mayform a biofilm which may be resistant to further treatment (Galiano etal (2007) in Grabb and Smith's Plastic Surgery, Lippincott Williams &Wilkins, Philadelphia, Pa.; herein incorporated by reference).

Since the early 1900s, the mainstay of wound treatment has beenirrigation and mechanical debridement. This technique decreasesbacterial counts and removes foreign bodies and necrotic tissue in whichbacteria can proliferate, and thus aids wound healing, decreases theincidence of infection, and reduces the bioburden of the wound.

As adjuncts to mechanical debridement and irrigation, there arecurrently several different types of chemical debridement andantimicrobial agents that are used to decrease bacterial counts andremove necrotic tissue. However, the efficacy of these agents inremoving biofilm and debriding necrotic tissue is minimal, as they donot penetrate the wound eschar and thus cannot reach the places wherebacteria may reside.

Negative pressure wound therapy (NPWT) is a recent advancement in woundcare. Among other beneficial actions, NPWT devices help remove bacteriaand their secreted enzymes, thereby reducing bacterial counts andsubsequently aiding wound healing. However, NPWT devices should not beused if necrotic tissue or active infection is present, and will notremove a biofilm or eschar. In addition, these devices are not meant tobe used in areas under pressure (such as in a sacral pressure sore) andalso require a cavity or indentation in the skin, which limits their usein superficial wounds.

Pulse lavage irrigation has been developed over the last 40 years andhas been repeatedly shown to effectively decrease bacterial counts inwounds more efficiently and effectively than conventional methods ofirrigation, including bulb syringe irrigation or gentle lavage, and isas effective at reducing bacterial counts as tangential hydrodissection(Granick et al (2007) Ostomy Wound Manag. 53:64-6, 68-70, 72; hereinincorporated by reference). Pulse irrigation can be used in wounds ofany depth or level of bacteria. At moderate pressures, pulse irrigationis non-injurious to viable tissue. In a small scale study using acaprine wound model and bioluminescent strain of Pseudomonas aeruginosa,pulse irrigation was shown to reduce bacterial counts more effectivelythan bulb irrigation (Svoboda et al (2006) J Bone Joint Surg. Am.88:2167-74; herein incorporated by reference). Finally, pulse lavage hasbeen shown to be more effective than whirlpool therapy in reducingbacterial counts (Krasner et al (2007) Chronic wound care: A clinicalsource book for healthcare professionals, 4^(th) ed, Alvern P A, HMPCommunications 331-342).

The major drawback to pulse lavage is that it is extremely messy and caneasily contaminate the patient's surroundings, putting other patientsand the person administering the treatment at risk. There have been casereports of pulse lavage irrigation spreading bacteria between patients(Maragakis et al (2004) JAMA 292:3006-11; herein incorporated byreference). Consequently, pulse lavage must be administered in acontrolled environment. This limits the availability of pulse lavage asa therapeutic option and renders it unpracticable at the bedside, inhome care and outpatient settings, and in military or fieldenvironments.

There is need in the art for improved methods of administering containedpulse lavage irrigation or contained pressurized non-pulsatileirrigation to aid wound healing.

SUMMARY OF THE INVENTION

The invention relates to the treatment of wounds. In particular, theinvention relates to systems, devices, and methods enabling treatment(e.g., debridement) of wounds with liquid, gas, or particles in anon-controlled setting while providing containment of contaminatedliquid, gas or particles, thereby preventing exposure of individuals andsurfaces in proximity to the patient to infectious materials. In certainembodiments, the systems and devices are conformable to the contours ofa non-planar surface, such as the human body (e.g., to seal or partiallyseal the device or system to a portion of a human body).

In some embodiments, the present invention provides systems and devicesfor wound irrigation comprising at least two, or all, of the followingcomponents: a) a wound-proximal membrane element; b) a base element,securable to the wound-proximal membrane element; c) a buffer component,wherein the buffer component is conformable to the contours of anon-planar surface, and wherein the buffer component is: i) securable tothe wound-proximal membrane element, ii) securable to the base element,iii) is securable to the wound-proximal membrane element and the baseelement, or iv) forms part of the base element; d) an upper housingelement, connectable to the base element, and bearing at least one portelement; e) a fluid introduction means or component, connectable to theat least one port element; and f) a fluid suction means or component,connectable to the at least one port element.

In certain embodiments, the buffer component is composed of a materialselected from the group consisting of: gel, foam, rubber, and spongematerial. In other embodiments, the buffer component is inflatable. Incertain embodiments, the buffer component comprises thin foil, pliableplastic, or silicon. In particular embodiments, the buffer component isconstructed in an accordion-style fashion. In further embodiments, thebuffer component is composed of a series of concentric shapes, whereineach shape in said series is larger than the preceding concentric shape.

In some embodiments, the invention comprises a wound-proximal membranethat provides a surface amenable to attachment of a base member of thedevice. In some embodiments, the wound-proximal membrane at leastpartially encompasses at least one wound site to which pulse irrigationlavage is to be directed. In some embodiments, the wound-proximalmembrane protects the tissue surrounding the wound from maceration ordamage during the pulse lavage irrigation procedure.

In some embodiments, the base member is affixed securely to thewound-proximal membrane. In some embodiments, dressing material at leastpartially encompasses the base member. In some embodiments, a housingelement is securely and reversibly attached to the base member. In someembodiments, the attachment forms a watertight seal. In someembodiments, the housing element and the base element are combined intoone element. In some embodiments, the housing element bears at least onedock serving as an introduction means for a port structure through whichpulsed lavage irrigation fluid or pressurized non-pulsatile irrigationis introduced, or material is removed. In some embodiments, the portstructure through which pulsed lavage irrigation fluid or pressurizednon-pulsatile irrigation is introduced is a nozzle. In some embodiments,the port and dock form a watertight seal. In some embodiments, the atleast one port and at least one dock comprise a structure permittingbetween 1° and 360° rotation of the nozzle. In some embodiments, thestructure permitting between 1° and 360° rotation of said nozzlecomprises a ball-in-cup design.

In some embodiments, the housing element bears at least one port throughwhich irrigation fluid is removed. In some embodiments, the portinterfaces with a dock. In some embodiments, the at least one port anddock form a watertight seal. In some embodiments, the removal ofirrigation fluid occurs via mechanically-induced suction. In someembodiments, the removal of irrigation fluid occurs withoutmechanically-induced suction. In some embodiments, the force or rate ofsuction is adjustable so as to optimize the rate of irrigation fluidremoval. In some embodiments, the port structure through which materialis removed is a nozzle that may move vertically into and out of thewound, as well as rotate up to 360 degrees, thus permitting the nozzleto remove material directly from the wound surface. In variousembodiments, the upper housing element, base element, and wound-proximalmembrane are of dimensions capable of encompassing wounds of at least0.5 cm; 0.5-1 cm; 1-5 cm; 5-10 cm; 10-20 cm; 20-50 cm; 50 cm-1 m; 1m-1.5 m; 1.5-2 m; or 2-3 m. In various embodiments, the upper housingelement, base element, and wound-proximal membrane are of dimensionscapable of encompassing wounds of various shapes, including but notlimited to circular wounds (e.g., puncture wounds, burns, abrasions,penetration wounds, gunshot wounds); linear wounds (e.g., cuts, slices,incisions, lacerations, blade-induced wounds); wounds with irregularshape (e.g., bedsores, ulcers, lacerations, tears, burns, abrasions).

In some embodiments, the housing element bears an additional at leastone dock for optimal positioning of irrigation fluid introduction meansand suction directionality. In some embodiments, unused docks are sealedwith a plug. In some embodiments, the at least one plug and dock forms awatertight seal. In some embodiments, the structures comprising anirrigation fluid introduction means and irrigation fluid suction meanscomprise tubing. In some embodiments, there is a plurality of saidtubing elements to permit multiple points of irrigation fluidintroduction and/or irrigation fluid suction. In some embodiments, thereis a connection means to bundle a plurality of irrigation fluidintroduction or irrigation fluid suction tubing. In some embodiments,the connection means comprises a Y-tube connector. In some embodiments,the connection means comprises a multi-point connector. In someembodiments, the connections between tubing may be reversible, allowingoptimal configuration of the tubing.

In some embodiments, the machine bears at least one place of attachmentfor at least one tubing, without limitation to the structural elementsof this connection. In one embodiment, the connection between the tubingand machine may comprise a screw structure. In one embodiment, theconnection between the tubing and machine may comprise a claspstructure. In one embodiment, the connection between the tubing andmachine may comprise an interlocking structure. In one embodiment, theconnection between the tubing and machine may comprise an interlockingcollar-and-sleeve structure. In one embodiment, the connection betweenthe tubing and machine may comprise a ball-and-socket structure. In someembodiments, the connection between the tubing and machine may form awatertight seal. In some embodiments, the connection between the tubingand machine may form an airtight seal. In some embodiments, the machinehas irrigation pressure controls. The pressure at which the irrigationfluid is applied may be at least 5 psi; 5-7 psi; 7-10 psi; 10-15 psi;15-20 psi; 20-25 psi; 25-30 psi; 30-40 psi; 40-50 psi; 50-75 psi; or75-100 psi. In some embodiments, the pressure at which the irrigationfluid is applied is manually or automatically selected (e.g. based onselected criteria (e.g. wound depth, would type, wound size, patientage, patient size, etc.)). In some embodiments, the pressure at whichthe irrigation fluid is applied is selected from a range (e.g. 5-40 psi,10-30 psi, 25-75 psi, 60-100 psi, 15-85 psi, etc.) within the range of5-100 psi. In some embodiments, the machine has irrigation pulsefrequency controls. The frequency at which the irrigation is pulsed maybe at least 1 pulse per second (e.g. 1-2 pulses per second, 2-5 pulsesper second, 5-10 pulses per second, 10-20 pulses per second, 20-50pulses per second, 50-100 pulses per second, etc.). In some embodiments,the irrigation is pulsed at regular or non-regular intervals. In someembodiments, the machine has a setting that allows continuousnon-pulsatile lavage. In some embodiments, the machine has a settingthat allows control over the flow rate of irrigation fluid. In someembodiments, the flow rate at which the irrigation is applied is atleast 0.05 liters per minute (e.g. 0.05-0.10 liters per minute,0.10-0.25 liters per minute, 0.25-0.50 liters per minute, 0.50-1.0liters per minute, 1-2 liters per minute, 2-5 liters per minute, 5-10liters per minute). In some embodiments, optimal flow rate is manuallyor automatically adjusted. In some embodiments, the machine has asetting that allows control over the force of suction. In someembodiments, the suction pressure is at least 1 mm hg (e.g. 1-10 mm hg,10-25 mm hg, 25-50 mm hg, 50-100 mm hg, 100-150 mm hg, 150-200 mm hg,200-300 mm hg, 300-400 mm hg, 400-700 mm hg, 700-1000 mm hg, etc.). Insome embodiments, the machine has a setting that allows the irrigationand suction to occur automatically. In some embodiments, the machine hasa setting that allows the movement of the suction and irrigation portsto occur automatically. In some embodiments, the machine is powered bybatteries. In some embodiments, the machine is powered by an externalpower source.

In some embodiments, the present invention provides a system for woundirrigation comprising (a) a wound-proximal membrane element, (b) a baseelement, securable to the wound-proximal membrane element, (c) an upperhousing element, connectable to the base element, and bearing at leastone port element, (d) a fluid introduction means, connectable to the atleast one port element, and a fluid suction means, connectable to the atleast one port element. In some embodiments, the fluid comprisesirrigation fluid. In some embodiments, the at least one port elementcomprises at least two port elements. In some embodiments, the fluidintroduction means is connected to one port element and the fluidsuction means is connected to a second port element. In someembodiments, the system further comprises a means of adjusting of fluidpressure. In some embodiments, the system further comprises one or moreirrigation nozzles for directing the flow of the fluid onto the wound.In some embodiments, the spray direction of one or more irrigationnozzles is manually controllable. In some embodiments, the spraydirection of one or more irrigation nozzles moves according to a pre-setprogram. In some embodiments, the upper housing element connects to thebase element by an interlocking mechanism. In some embodiments, theupper housing element connects to base element by a screw-in mechanism.In some embodiments, the base element securably attaches to thewound-proximal membrane element by an adhesive. In some embodiments, thebase element securably attaches to the wound-proximal membrane elementby a locking mechanism. In some embodiments, the wound-proximal membraneelement adheres to a subject proximal to a wound on the subject.

In some embodiments, the present invention provides a method foradministering an irrigation fluid to a wound comprising: (a) placing thesystem on the wound of a subject, (b) administering irrigation fluids tothe wound, and (c) sequestering the irrigation fluids by the systemfollowing contact with the wound. In some embodiments, the irrigationfluid is administered via pulse lavage irrigation. In some embodiments,the irrigation fluid is administered via pressurized non-pulsatileirrigation.

In certain embodiments, the nozzle includes an internal or externalstructure to create laminar flow. In further embodiments, the nozzle isconfigured such that is has a round form on one aspect that allows it tosit in the housing structure and rotate. Alternatively the nozzle maynot rotate and may be fixed in place.

In some embodiments, the present invention provides systems and devicesfor wound treatment (e.g., debridement) comprising: a) a base element,reversibly securable to a wound-proximal membrane element; b) an upperhousing element, connectable to the base element, and bearing at leastone port element, wherein the at least one port element may be or isconnectable to a suction component; and c) a buffer component that is aseparate component or forms part of the base element, wherein the buffercomponent is conformable to the contours of a non-planar surface, andwherein the buffer component is: i) reversibly or irreversibly securableto the wound-proximal membrane element, ii) reversibly or irreversiblysecurable to the base element, iii) is reversibly or irreversiblysecurable to the wound-proximal membrane element and the base element,and/or iv) is reversibly or irreversibly securable to the upper housingelement.

In certain embodiments, the systems and devices further comprise thewould proximal membrane element. In other embodiments, the at least oneport element comprises first and second port elements, and wherein thefirst port element is connectable to the suction component, and thesecond port element is connectable to a material introduction component.In additional embodiments, the material introduction component isconfigured to introduce liquid, gas, or solid particles. In certainembodiments, the liquid comprises irrigation fluid. In additionalembodiments, the material introduction component is connected to thefirst port element. In other embodiments, the systems and devicesfurther comprise one or more nozzles for directing the flow of materialonto the wound. In further embodiments, the housing element connects tothe base element by an interlocking mechanism, by magnets, or by ascrew-in mechanism. In additional embodiments, the base elementsecurably attaches to the wound-proximal membrane element by anadhesive. In certain embodiments, the wound-proximal membrane elementadheres to a subject proximal to a wound on the subject. In someembodiments, the buffer component is composed of a material selectedfrom the group consisting of: gel, foam, rubber, PETG plastic, pliableplastic, thin foil, silicone, and sponge material.

In some embodiments, the present invention provides methods of treating(e.g., debridement) a wound comprising: a) placing a containment systemon the outer surface of a subject such that at least part of a wound isenclosed and such that the containment system conforms to the outersurface of the subject creating a seal, wherein the containment systemcomprises a housing and at least one port component; and b) introducingand/or removing liquid, gas, or particles via the at least one portcomponent such that at least partial treatment (e.g., debridement) ofthe wound is achieved without leakage of the liquid, the gas, and theparticles outside of the containment system (e.g., leakage into thetreatment environment).

In certain embodiments, the containment system further comprises a baseelement that is conformable to the outer surface of the subject. Inother embodiments, the base element is flexibly attached to the housing.In additional embodiments, the base element is reversibly attached tothe housing. In particular embodiments, the containment system furthercomprises a buffer component that is conformable to the outer surface ofthe subject. In additional embodiments, the buffer component is flexiblyattached to the base element. In particular embodiments, the buffercomponent is reversibly attached to the base element. In furtherembodiments, the wound comprises a biofilm, and wherein the introducingand removing removes all or part of the biofilm.

In some embodiments, the seal is an airtight seal, liquid tight seal,and/or particle tight seal. In additional embodiments, the liquid isirrigation fluid which is administered via pulse lavage irrigation(e.g., and a wound with a biofilm is treated such that the biofilm issubstantially removed). In certain embodiments, the liquid is irrigationfluid which is administered via pressurized non-pulsatile irrigation(e.g., and a wound with a biofilm is treated such that the biofilm issubstantially removed). In additional embodiments, the introducingand/or removing liquid, gas, or particles comprises removing gas suchthat negative pressure is applied to the wound.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of a device. A, upper housing element; B,base element; C, wound-proximal membrane. Elements are shown in aseparated state and are in an assembled state during wound irrigationtherapy.

FIGS. 2A-C show several non-limiting exemplary embodiments for the upperhousing element connection to the base element via a screw structure(e.g. threading); B, interlocking structure (e.g. lock-in place); C,notched-fit.

FIGS. 3A-B show non-limiting exemplary embodiments for the base memberconnection to the wound-proximal membrane. FIG. 3A shows thewound-proximal membrane without an over-lying ridge and FIG. 3B showsthe wound-proximal membrane with an over-lying ridge for furthersecuring to the base member.

FIGS. 4A-B show an embodiment of the wound-proximal membrane componentfrom both an perspective view (4A) and a top-down view (4B).

FIGS. 5A-D show non-limiting exemplary embodiments of: A, suctionport(s); B/C, irrigation nozzle element(s); and D, plug elements.

FIGS. 6A-D show several non-limiting exemplary embodiments of the basemember element and upper housing element, and connection thereof,including a rectangle shape (6A), circle shape (6B), a rectangle shapewith pyramid shape for upper housing element (6C), and circle shape withcenter raised portion (6D).

FIG. 7, panel A shows one embodiment of forming the buffer componentfrom a series of concentric circles. Panel B shows one embodimentshowing an according-style for the buffer component.

FIGS. 8A-C show the upper housing of the element. FIG. 8A. shows a sideview of an upper housing element (left side) and base component withintegrated buffer component (right side). FIG. 8B shows a top down viewof an upper housing element (left side) and base component withintegrated buffer component (right side). FIG. 8C shows a side view ofan upper housing element reversibly attached to a base component viamagnets on the two components.

DEFINITIONS

As used herein, the term “wound” refers broadly to injuries to tissueincluding the skin, subcutaneous tissue, muscle, bone, and otherstructures initiated in different ways, for example, surgery, (e.g.,open post cancer resection wounds, including but not limited to, removalof melanoma and breast cancer etc.), contained post operative surgicalwounds, pressure sores (e.g., from extended bed rest) and wounds inducedby trauma. As used herein, the term “wound” is used without limitationto the cause of the wound, be it a physical cause such as bodilypositioning as in bed sores or impact as with trauma or a biologicalcause such as disease process, aging process, obstetric process, or anyother manner of biological process. Wounds caused by pressure may alsobe classified into one of four grades depending on the depth of thewound: i) Grade I: wounds limited to the epidermis; ii) Grade II: woundsextending into the dermis; iii) Grade III: wounds extending into thesubcutaneous tissue; and iv) Grade IV: wounds wherein bones are exposed(e.g., a bony pressure point such as the greater trochanter or thesacrum). The term “partial thickness wound” refers to wounds that arelimited to the epidermis and dermis; a wound of any etiology may bepartial thickness. The term “full thickness wound” is meant to includewounds that extends through the dermis.

As used herein, “wound site” refers broadly to the anatomical locationof a wound, without limitation.

As used herein, the term “acute wound” refers to a wound that has nothealed within 30 days.

As used herein, the term “chronic wound” refers to a wound that has nothealed in a time period greater than 30 days.

As used herein, the term “subject” refers to both humans and animals,including, but not limited to, a dog, cat, bird, livestock, andpreferably a human.

As used herein, the term “dressing” refers broadly to any materialapplied to a wound for protection, absorbance, drainage, treatment, etc.Numerous types of dressings are commercially available, including films(e.g., polyurethane films), hydrocolloids (hydrophilic colloidalparticles bound to polyurethane foam), hydrogels (cross-linked polymerscontaining about at least 60% water), foams (hydrophilic orhydrophobic), calcium alginates (nonwoven composites of fibers fromcalcium alginate), and cellophane (cellulose with a plasticizer) (Kannonand Garrett (1995) Dermatol. Surg. 21: 583-590; Davies (1983) Burns 10:94; each herein incorporated by reference). The present invention alsocontemplates the use of dressings impregnated with pharmacologicalcompounds (e.g., antibiotics, antiseptics, thrombin, analgesiccompounds, etc). Cellular wound dressings include commercially availablematerials such as Apligraf®, Dermagraft®, Biobrane®, TransCyte®,Integra® Dermal Regeneration Template®, and OrCell®.

As used herein, “treatment environment” refers broadly to thesurroundings of the individual receiving treatment, without limitation.These surroundings include but are not limited to a hospital, a clinic,a bedside, a residence, a battlefield, a trauma center, or a fieldenvironment.

As used herein, “adhesive” refers to any material with adherentproperties used to affix one structure to another, including but notlimited to the source of the substance (synthetic or natural) or thestrength of the adhesion.

As used herein, “wound-proximal membrane” refers to a structure at leastpartially encompassing or covering at least one wound site withoutlimitation to the nature of the material used for its construction andmay or may not partially encompass some aspect of the “base”, be thatmaterial synthetic or natural, and without limitation to its physicalattributions including hardness, thickness, height, width, depth, shape,or transparency.

As used herein, “base” refers to a component of a device that is incontact with the subject, a wound-proximal membrane, or a buffercomponent; and the housing element. In one embodiment, the base elementis separable from the housing element. In another embodiment, the baseelement is integrated with the housing element. In one embodiment, baseelement B (FIG. 1) has adhesive properties on its underside so that itadheres in a waterproof fashion to wound-proximal membrane C (FIG. 1) orto the patient directly, and has a waterproof locking mechanism thatjoins it to upper housing element A (FIG. 1), thereby permitting removalof the upper housing element, without limitation to the structuralelements of this connection. In one embodiment, the connection betweenthe base and upper housing element may comprise a screw structure. Inone embodiment, the connection between the base and upper housingelement may comprise a clasp structure. In one embodiment, theconnection between the base and upper housing element may comprise aninterlocking structure. In one embodiment, the connection between thebase and upper housing element may comprise an interlockingcollar-and-sleeve structure. In one embodiment, the connection betweenthe base and upper housing element may comprise a ball-and-socketstructure. In some embodiments, the connection between the base andupper housing element may form a watertight seal. The identity of thebase element is not limited by the nature of the material used for itsconstruction, be that material synthetic or natural, and withoutlimitation to its physical attributions including hardness, thickness,pliability, height, width, depth, shape, diameter, or transparency.

As used herein, “housing” refers to a component of a device thatcompletely or partially defines a chamber continuous with a wound site.The housing may or may not have one or more orifices that serve to allowconnections between other structures of the device. The identity of thehousing element is not limited by the nature of the material used forits construction, be that material synthetic or natural, and withoutlimitation to its physical attributions including hardness, thickness,pliability, height, width, depth, shape, diameter, or transparency. Incertain embodiments, the housing has a low profile (e.g., not a dome).In particular embodiments, the input/output ports and docks may belocated on the sides of the of the structure.

As used herein, “dock” refers to an orifice in a housing element thatserves as a means of connection between structures or elements of adevice used for contained pulse lavage irrigation, or containedpressurized non-pulsatile irrigation or removal of material from thechamber continuous with the wound site, without limitation to thestructural elements of this connection. In one embodiment, theconnection between the dock and other structural elements may comprise ascrew structure. In one embodiment, the connection between the dock andother structural elements may comprise a clasp structure. In oneembodiment, the connection between the dock and other structuralelements may comprise an interlocking structure. In one embodiment, theconnection between the dock and other structural elements may comprisean interlocking collar-and-sleeve structure. In one embodiment, theconnection between the dock and other structural elements may comprise aball-and-socket structure. In some embodiments, the connection betweenthe dock and other structural elements may form a watertight seal. Theidentity of a dock element is not limited by the nature of the materialused for its construction, be that material synthetic or natural, andwithout limitation to its physical attributions including hardness,thickness, pliability, height, width, depth, shape, or transparency.

As used herein, “port” refers to a structural element that fits into thedock and may allow the introduction of pulse lavage irrigation, orpressurized non-pulsatile irrigation, into the housing chambercontiguous with the wound, or removal of material from the housingchamber, or serve another function related to the use of the device. Inone embodiment, the port may comprise a nozzle that allows theintroduction of pulse lavage irrigation, or pressurized non-pulsatileirrigation into the housing chamber contiguous with the wound. In oneembodiment, the port may comprise a suction nozzle that allows removalof material from the housing chamber contiguous with the wound. In oneembodiment, the port may comprise a plug that fits into a dock andserves to block the orifice of the dock in order to prevent the effluxof material from the housing chamber. In one embodiment, the plug maycontain one or more perforations or hole to allow ventilation during theuse of the device. The identity of a port is not limited by the natureof the material used for its construction, be that material synthetic ornatural, and without limitation to its physical attributions includinghardness, thickness, height, pliability, width, depth, shape, ortransparency.

As used herein, “tubing” refers to a structure that provides a means bywhich to introduce material into the chamber continuous with the woundsite, or remove material from the chamber continuous with the woundsite. The identity of a tubing element is not limited by the nature ofthe material used for its construction, be that material synthetic ornatural, and without limitation to its physical attributions includinghardness, thickness, height, pliability, width, depth, shape, diameter,or transparency. In certain embodiments the tube (e.g., suction tube)may have a modification on the surface that enters the housing of thedevice. This may take the form of an enlargement or protrusion, a roughsurface, without limitation to the structural elements of modification.The purpose of this is to allow the suction tube to gently scrape thesurface of the wound in order to perform some element of mechanicaldebridement.

As used herein, “machine,” when used in reference to a component ofsystems described herein, refers to a structure that propels the fluidinto the tubing and into the chamber and may or may not provide a forcethat removes the fluid from the chamber. The identity of a machine isnot limited by the nature of the material used for its construction, bethat material synthetic or natural, and without limitation to itsphysical attributions including hardness, thickness, height, pliability,width, depth, shape, or transparency

As used herein, “irrigation fluid” refers broadly to any materialintroduced into the chamber continuous with a wound site during theapplication of contained pulse lavage irrigation, or containedpressurized non-pulsatile irrigation. In one embodiment, the irrigationfluid is a gas. In a preferred embodiment, the irrigation fluid is aliquid. The irrigation fluid is not limited to any particular type orcomposition, including normal saline solution, buffer solution,antibiotic solution, bacteriostatic solution, antiseptic solutionincluding Betadine® solution, surfactant solution, soap solution, or anycombination thereof. In one embodiment, the irrigation fluid is normalsaline. The irrigation fluid may include additional agents administeredfor therapeutic or analgesic properties including but not limited tothrombin, analgesic agents, growth factors, collagen-active agents, or acombination thereof. The irrigation fluid is not limited by the volumeadministered during each incidence of therapy which may comprise atleast 0.01-0.1 L; 0.1-0.5 L; 0.5-1 L; 1-2 L; 2-3 L; 3-4 L; 4-5 L; 5-10L; 10-20 L; 20-30 L; 30-40 L; 40-50 L; 50-100 L. The irrigation fluid isnot limited by the nature of its physical attributes including but notlimited to viscosity, color, transparency, temperature, pH, or density.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to the treatment of wounds. In particular, theinvention relates to systems, devices, and methods enabling treatment(e.g., debridement) of wounds with liquid, gas, or particles in anon-controlled setting while providing containment of contaminatedliquid, gas or particles, thereby preventing exposure of individuals andsurfaces in proximity to the patient to infectious materials. In certainembodiments, the systems and devices are conformable to the contours ofa non-planar surface, such as the human body (e.g., to seal or partiallyseal the device or system to a portion of a human body).

An embodiment of the invention as shown in FIG. 1 contains the followingelements as described herein. In some embodiments, an irrigation deviceor system of the present invention comprises an upper housing, baseelement, and wound-proximal membrane. The system/device may alsocomprise an irrigation device, waste removal/storage device, pressuregauge, etc. It should be understood that this is an exemplary embodimentand that the invention is not limited to the specific features of thisembodiment. In some embodiments, two or more of the elements of FIG. 1are contained within a single element (e.g. upper housing element andbase element, base element, and wound-proximal element, upper housingelement, base element, and wound-proximal element). In some embodiments,the irrigation device is configured to engage and disengage the upperhousing element. In some embodiments, the irrigation device and theupper housing element comprise a single unit. In some embodiments, thesuction means is configured to engage and disengage the upper housingelement. In some embodiments, the suction means and the upper housingelement comprise a single unit.

Structural element C: A wound-proximal membrane. In some embodiments,the wound-proximal membrane comprises one or more membranes, sheets,films, and/or layers which contact the subject, wound, an/or areasurrounding the wound to present a working field to the other portionsof the device/system. The wound-proximal membrane may comprise differentlayers which are adhesive, fluid resistant, permeable, semi-permeable,impermeable, absorbent, breathable, and/or padded. In some embodiments,the specific make-up of the wound-proximal membrane is selected for thespecific requirements of the subject, wound, and or irrigationprocedure. In some embodiments, the wound-proximal membrane ispermeable, semi-permeable, or impermeable to fluid (e.g. body fluids,irrigation fluids, water, etc.). In some embodiments, the wound-proximalmembrane has a cut made in the center and a surrounding area ofincomplete perforations or microperforations (such as is found in piecesof paper to facilitate “tearing along the dotted line”) (SEE FIG. 4).The center cut may be of any suitable shape (e.g. an “x” shape, acircle, a line, etc.) and size. The perforations may be of any suitableconformation (e.g. ordered, random, linear, etc.) and/or number. In someembodiments, a wound-proximal membrane may comprise more than onecenter-cut. The cut is centered over the wound, and an area thatcontours to the wound edges is removed from the membrane, beginning fromthe pre-cut incision. An appropriate size and/or shape of wound-proximalmembrane may be selected to appropriately suit a specific wound. If thewound is large and the base does not encircle the entire wound, the onlyarea of the membrane that should be removed is the area within theperimeter of the base so that the irrigation and suction can take placeunhindered. In some embodiments, only a portion of the wound is revealedto the irrigation fluid from beneath the wound-proximal membrane. Thecut and the perforations facilitate tearing the membrane, or themembrane may be cut or trimmed to fit with scissors or other instrument.Alternatively, the center of the membrane may be trimmed/torn prior toplacement on the patient if necessary. The purpose of the membrane is toprotect the surrounding skin from maceration as well as to create auniform surface upon which the base element may attach. This gives thebase element a closer contour to the shape of the body, and helps sealthe base element. The membrane may be a thin adhesive membrane, or mayalternatively be composed of a thicker padding such as foam or softrubber to help pad the wound edges and even the contour to achieve abetter fit with the base element. The membrane may comprise any suitablematerial or materials (e.g. synthetic materials, natural materials,polymers, fibers, textiles, glass, plastic, metal, etc.). In someembodiments, the wound-proximal membrane is flat and engages the baseelement through suction or an adhesive. In some embodiments, the topside of the wound-proximal membrane comprises a rim element for engagingthe base element (e.g. SEE FIG. 3). In some embodiments, a rim elementand base element engage through an engagement mechanism (e.g. lipstructure) (SEE FIG. 3B). In some embodiments, the rim element of thewound-proximal membrane enhances the seal between the base element andthe wound-proximal membrane. In some embodiments, engagement between thebase element and wound-proximal membrane is sufficient without a rimelement. In some embodiments, negative pressure within the system/deviceenhances the interaction between the wound-proximal membrane and baseelement.

Structural element B: At least one base element is placed over the woundsite. Alternatively, the at least one base element may be placed on themembrane before the housing element is placed on the wound.Alternatively, the base element is placed directly on or around thewound. The base element may adhere to the wound-proximal membrane via anadhesive surface on its underside. In some embodiments, the base elementdoes not have to encircle the entire wound site, but should be locatedat least partially over the wound. In some embodiments, the base elementsurrounds the wound. Both the base element and the wound-proximalmembrane are intended to remain on the wound site as long as the deviceis used, but may be replaced as necessary. The base element may havesolely adhesive on its underside, or adhesive padding such as a softrubber, silicone, or water-proof foam. The base element may be of anysuitable shape (e.g. circular, ovular, square, rectangular, etc.) orsize to best interact with the other elements of the device (e.g. upperhousing and wound-proximal membrane) and properly engage the wound. Insome embodiments, the inner diameter or perimeter of the base element isconfigured and sized for interaction with a upper housing element. Insome embodiments, the outer diameter or perimeter of the base element isconfigured and sized for interaction with a upper housing element. Insome embodiments, the inner diameter or perimeter of the base element isconfigured and sized for interaction with a wound-proximal membrane. Insome embodiments, the outer diameter or perimeter of the base element isconfigured and sized for interaction with a wound-proximal membrane. Thebase element may be of any suitable shape and size. In some embodiments,the shape and size of the base element is selected based oncase-specific criteria (e.g. wound size, wound shape, patient size,wound location, etc.).

Additional adhesive dressing or membrane may be placed around theperimeter lip of the base, to further seal it onto the wound-proximalmembrane and to prevent the escape of irrigation fluid. This may alsoremain in place as needed. The additional dressing may have a pre-cutorifice that conforms to the outer perimeter lip of the base element,and should be attached after the base is placed on the other adhesivedressing.

Structural element A: The upper housing element. In some embodiments,the upper housing element is temporarily secured to the base element toform a watertight junction. In some embodiments, the upper housingelement provides entry and exit points (e.g. ports, valves, etc.) forirrigation fluid (SEE FIG. 1). In some embodiments, the upper-housingelement may be of any suitable shape (e.g. dome (SEE FIG. 2), flat (SEEFIG. 6A/B, pyramidal (SEE FIG. 6C), etc.) and size. In some embodiments,the shape and size of the upper housing is selected based oncase-specific criteria (e.g. wound size, wound shape, patient size,wound location, etc.). In some embodiments, the shapes and sizes of theupper housing element, base element, and wound-proximal membrane areselected to complement each other and function in conjunction (SEE FIGS.1, 2, 3, and 6).

Different embodiments for the junctions between the upper housing, baseelement, and wound-proximal membrane are exemplified in FIG. 2 and FIG.3. Examples of the upper housing and base element junction include screw(SEE FIG. 2A), snap, fit (SEE FIG. 2C), lock, or clasp mechanisms (SEEFIG. 2B), or other means that provide for a watertight junction (e.g.temporary watertight junction). The inferior bottom of the upper housingelement may rest within the inner perimeter of the base, with thelateral bottom of the upper housing element resting on top of the base.The upper housing element may be removed from the base element betweenuses to allow the wound to be dressed in any manner desired. In someembodiments, the junction between the upper housing and the base elementis configured for routine and repeated engagement and disengagement. Insome embodiments, the upper housing comprises 1 or more docks or ports(e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . . . 20, etc.) for engagement ofother device elements including, but not limited to means for providingirrigation fluid, suction means, etc. In some embodiments, docks and/orports are generically configured for attachment to any additional deviceelements. In some embodiments, ports and/or docks are configured forattachment to a specific element (e.g. irrigation means, suction means,pressure monitoring means, etc.).

Additional structural elements, as described herein:

The suction tubing (SEE FIG. 5A), irrigation nozzle(s) (SEE FIG. 5B/C),and plug(s) (SEE FIG. 5D) may be attached to the upper housing elementeither before or after it is secured to the base element. When aplurality of docks is present, these accessories can be interchangeablyand reversibly placed within the various docks in order to optimizesuction and irrigation. In a preferred embodiment, the seal between thedocks and accessories is watertight and/or airtight.

The suction and irrigation tubing is secured at one end to theirrigation nozzles and suction nozzles, and at the other end to themachine(s). The tubing may be separated from the upper housing elementand the machine(s) between uses to prevent contamination. The connectionbetween the nozzle or other irrigation fluid introduction structure andthe tubing as well as the connection between the machine(s) and thetubing is secure enough to withstand movement but also easily released.If more than one suction tube or irrigation nozzle is to be used on theupper housing element, Y tubing or a multi-point connection can be usedto attach multiple nozzles or suction tubes to the upper housingelement. In some embodiments, suction and/or irrigation tubing containsone or more valves, ports, splitters, etc. In some embodiments, suctionand/or irrigation tubing is attached to the upper housing elements atone or more ports and/or docks (e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . . .20, etc.). In some embodiments, the present device comprising tubing ofany suitable configuration required for the specific irrigation task.

After connecting the machine to a supply of irrigation fluid, themachine is turned on, and the irrigation is controlled by aiming theflow via manual manipulation of irrigation nozzle(s). In an alternativeembodiment, the movement of the irrigation nozzles and suction nozzlesis automated. The irrigation nozzle(s) has 360° rotational movementwithin the upper housing element. In one embodiment, this freedom ofmovement is provided by a “ball in cup” design. This freedom of movementallows targeted pulse irrigation for optimized removal of biofilm. Inone embodiment, fluid is removed by manipulating the suction ports,which have free vertical movement and at least some horizontal movement.In some embodiments, the machine which supplies irrigation fluidcomprises a single unit with the upper housing element. In someembodiments, the machine to a supply of irrigation fluid engages theupper housing element at an irrigation hose or tube, dock, port, and/orinlet valve.

After sufficient irrigation, the upper housing element and tubing areremoved, and the wound covered and dressed per routine. In someembodiments, the pulse irrigation and/or suction machines are re-usableand when properly used do not result in cross-contamination betweenpatients. In an alternative embodiment, the machine is disposable. Insome embodiments, the wound-proximal membrane, dressing, and all othercomponents of the device are disposable and are discarded after thepatient has completed therapy. In one embodiment, the disposablecomponents are packaged together and the machine(s) are packagedseparately.

Wound-proximal membrane, base element(s), and upper housing element(s)are available in a variety of sizes and shapes (e.g. circular, ovular,square, rectangular, etc.) to allow optimal irrigation on differentwound sites regardless of anatomical position or size of the wound. Insome embodiments, a kit is provided containing a plurality of componentsof different sizes and shapes that can be mixed and matched as needed.

In some embodiments, the upper housing element, base element, andwound-proximal membrane are of dimensions capable of encompassing woundsof a variety of diameters. In some embodiments, the upper housingelement, base element, and wound-proximal membrane are of dimensionscapable of encompassing wounds of a variety of shapes.

In some embodiments, the upper housing element and base element areconstructed to permit the application of negative pressure to the wound.In some embodiments, absorbent material (e.g., sponge, etc.) is includedwithin the wound-proximal chamber. In some embodiments, negativepressure is applied to the wound by the application of suction. Infurther embodiments, excess fluid or wound-produced fluid is removedthrough a nozzle that may move vertically into and out of the wound,thus permitting the nozzle to remove material directly from the woundsurface.

In certain embodiments, the systems and devices are conformable to thecontours of a non-planar surface, such as the human body (e.g., to sealor partially seal the device or system to a portion of a human body). Insome embodiments, a buffer component is employed to allow the devices ofthe present invention to seal or partially seal with a portion of a bodythat has a wound. In particular embodiments, the buffer component isdifferentially compressible so that on one of its surfaces, the sealover the contours of the body is maintained and the buffer component isstill capable of attaching to the less flexible dome.

In buffer component can broadly be described as a component that may bea separate or integrated piece of the device that adapts the device tothe curved surfaces of the body. The buffer component may enclose theentire wound, may enclose part of the wound, or may rest on top of orwithin the wound, without limitation to the structural elements of theconnection between the buffer and the body. The buffer component mayattach directly to the wound, or may rest on top of an adhesivedressing, which attaches to the wound. On one surface, the buffercomponent may adhere to the body via an adhesive. On one surface, thebuffer component may adhere to the body via a separate or integratedsuction mechanism. On one surface, the buffer component may adhere tothe body via straps or belts or other fasteners. On the other surface,the buffer component may adhere to the other components of the devicewithout limitation to the structural elements of the connection. Thisconnection may be reversible or irreversible. On the other surface, thebuffer component may attach to the other components of the device, forexample, via an adhesive, via an interlocking mechanism, via a screwmechanism, via a ball and socket mechanism, via a half turn mechanism,etc. In some embodiments, the buffer component is intended to remain onthe patient between uses. In another embodiment, the buffer component isintended to be removed between uses. The shape of the buffer componentmay be the same or different size or shape than the base. The buffercomponent may be of uniform or non-uniform size and shape, and may havea differential shape so that it serves as a connector or adaptor betweena base and a housing that are of different shapes.

In certain embodiments, the buffer component is composed of a series ofconcentric shapes (e.g., that rest on or around the wound). In oneembodiment, these comprise a series of concentric rings, with the sameor different thickness, and the same or different width, with increasingdiameter. Each shape in this series is larger than the shape precedingit. These shapes may all be connected to another structure via aflexible and pliable material such as a thin plastic sheet or foil. Thestructure that is connected to the concentric shapes may be comprised ofa ring or other shape, and is designed to attach to the dome or housingpiece of the main device without limitation to the structural elementsof the connection. This connection may be reversible or irreversible.This attachment may be comprised of an adhesive, an interlockingmechanism, a screw mechanism, a ball and socket mechanism, a half turnmechanism, or any other temporary or permanent mechanism, and may forman air and water tight seal. Each of the concentric shapes individuallyconnects to the same or different other structure. The material used forthe connection may have an incomplete perforation that extends aroundthe perimeter of the material, either near the concentric shapes or nearthe other structure to facilitate tearing. This is designed so that theconcentric shape of the proper size can be placed around or over thewound and the other shapes can be removed, while maintaining theconnection to the other structure which will connect to the housing partof the device. One embodiment of forming the buffer component from aseries of concentric circles is shown in FIG. 7A.

In another embodiment, the buffer component is composed of a materialthat is constructed in an accordion-style fashion, whereby the materialis folded or compressed in such a fashion that it different parts of itmay be decompressed or unfolded while other parts remain compressed orfolded. In this embodiment, the buffer component may be composed of, forexample, plastic, metal, foil, silicone, without limitation to the typeof material used in this composition. In this embodiment, the buffercomponent may adhere to the patient surface beneath the base of the maindevice, above the base of the device and below the connection to thebase, or above the connection to the base and below the dome. Oneembodiment showing an according-style for the buffer component is shownin FIG. 7B.

In another embodiment, the buffer component is composed of a flexiblematerial that may or may not add any structural support to the devicesuch as a thin foil or a thin piece of plastic (e.g., similar to aplastic bag). In this embodiment, the buffer component serves as anattachment between two components of the device, or between the patientand one component of the device, and by virtue of the fact that thebuffer component does not lend structural support, it allows relativemovement between elements of the device. In this embodiment, the buffercomponent may adhere to the patient surface beneath the base of thedevice, above the base of the device and below the connection to thebase, or above the connection to the base and below the dome.

In another embodiment, the buffer component is composed of a materialthat is differentially compressible so that when pressure is applied,different areas of the buffer component may have different heights andwhen pressure is released, the buffer component may or may not return toits original configuration. In this embodiment, the buffer component maybe composed of, for example, a gel, a foam, a rubber, a sponge, or anyother differentially compressible material that allows part of thebuffer component to be compressed while other part(s) are variablycompressed. In this embodiment, the buffer component may adhere to thepatient surface beneath the base of the device, above the base of thedevice and below the connection to the base, or above the connection tothe base and below the dome.

In another embodiment, the buffer component is composed of an inflatablestructure into which a gas or fluid can be injected. In this embodiment,inflation of the structure with either gas or fluid will allow thebuffer to be differentially compressible, and maintain its attachmentsto the patient and to the remainder of the system. In this embodiment,the buffer may adhere to the patient surface beneath the base of thedevice, above the base of the device and below the connection to thebase, or above the connection to the base and below the dome.

In some embodiments, a system is provided comprising one or more of theabove components as well as, optionally, instructions for use, computerequipment and software, or other components for using, monitoring, orautomating one more or more components of the system.

1.-24. (canceled)
 25. A system for wound irrigation comprising: awound-proximal membrane element comprising an opening that extends abouta wound to be irrigated; a base element to be coupled to thewound-proximal membrane element, the base element being conformable tocontours of a non-planar surface; an adhesive that is to adhere the baseelement to the wound-proximal membrane element and promote formation ofa seal that interferes with fluid flow between the base element and thewound-proximal membrane element; an upper housing element integrallyformed as a monolithic unit with the base element, and defining at leasta first aperture; irrigation fluid that, when introduced to the wound,promotes healthy closure of the wound; and an irrigation fluid deliveryconduit extendable through the first aperture of the upper housing toform a substantially water-tight seal with the upper housing and conveythe irrigation fluid from an external machine into an interior of theupper housing continuous with the wound.
 26. The system of claim 25further comprising padding to be disposed between a proximate surface ofthe base element and a subject with the wound to be irrigated
 27. Thesystem of claim 26, wherein the padding and the adhesive are combinedinto a single layer of material.
 28. The system of claim 25 furthercomprising a suction device extending into the interior of the housingto remove a portion of the irrigation fluid that has come into contactwith the wound.
 29. The system of claim 25 further comprising a ventthat ventilates the interior of the housing during use of the system.30. The system of claim 25, wherein the irrigation fluid comprises oneor more of: a saline solution, a buffer solution, an antibioticsolution, a bacteriostatic solution, an antiseptic solution, asurfactant solution, and a soap solution.
 31. The system of claim 25,wherein the seal is water tight.
 32. The system of claim 25, wherein theirrigation fluid delivery conduit comprises a nozzle that directs theirrigation fluid toward the wound and also removes a portion of theirrigation fluid that has been introduced into the wound.
 33. The systemof claim 25, wherein at least one of the base element and the upperhousing comprises a shape configured specifically to accommodate a shapeof the wound to be irrigated.